Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Tuesday, July 04, 2017

Seeking Miraculous Recoveries

"Stem cells have to be controlled to act exactly the way you want them to act. And that's why the research takes time."
"It is simply wrong for these clinics to take a proof of concept and run with it."
Ubaka Ogbogu, health law professor, University of Alberta

"I believe medical progress is not just limited to the laboratory and randomized double-blind trials. A lot of progress starts in the clinic, dealing with patients. You see something works, you see something has merit, and then it's usually the scientists that seem to catch up later."
"[Injections performed at Regenervate are comprised of] minimally manipulated [tissue derived from patients' own bodies. Any regulating effort to crack down would represent] regulation for the sake of regulation."
Dr. Douglas Stoddar, medical director, Regenervate

"There's a need for understanding what's going on here, and there's a need for regulation."
Dr. David Hart, orthopedic surgery professor, University of Calgary
Stem cell research Getty Images
There has been an appearance of clinics in Canada's large cities eager to provide treatment that falls into the realm of unproven and still experimental though it holds out the promise of opening a wholly new area of vital health treatments whose use seen to be premature, given the possibility of things going awry. Yet there are those people at their wit's end over their state of debilitation from conditions such as arthritis who seek out this kind of treatment despite its unauthorized conditions, who are willing to pay handsomely for the opportunity to improve their physical well-being.

Stem cell treatment has been available for years in Mexico, China, or Arizona, and medical practitioners who respect the process of introducing new treatments after successful experimentation, human trials and government approval, view the medical tourism that leads to access in stem-cell transplants as of dubious value. But it is its potential value that has inspired Canadians, among other nationals, to seek out the treatment in the hopes it will result in improved mobility and freedom from pain and discomfort.

Regenervate is the name given to a number of branches of the clinic in operation in Canada, which have initiated injections of stem cells lately to meet the growing demand. There are many other clinics, and their presence and treatment methodology has raised questions, on a medical hypothesis holding out future promise being used routinely before its full value is proven, and discounting concerns over possible complications. Arthritis is now being increasingly treated in clinics in Ontario and Alberta; along with joint injuries, disc problems and skin conditions.

Stem cells are derived from fat tissue or bone marrow from the patient him/herself. Stem cells are capable of "differentiating" or transforming into other types of cell allowing them to grow or to "regenerate" tissue that has been damaged through the onset of disease or by injuries suffered. Hundreds of researchers in Canada have been engaged in examining stem-cell treatments for all manner of conditions, from heart problems to severed spinal cords.

The problem is that it remains a concept yet to be proven to be fully effective and safe. Studied in a laboratory environment or in human trials, few treatments have yet been definitively proven to be effective by the techniques of science, let alone approved by regulators such as Health Canada. In the United States, three women became blind as a result of receiving stem-cell injections in their eyes. Others in the United States have developed bony masses or tumours at injection sites.

While some experts in the field feel that the procedures available at clinics such as Regenervate that focus on joint pain are relatively safe in all likelihood, they do express reservations that stem cells have the capability of developing into the wrong type of tissue, possibly in the wrong place in the body, and care must be taken with their use as a result. Fees at Regenervate range from $750 to $3,900, according to Dr. Stoddard, who is himself confident of the method's effectiveness and safety.

He cites the observation that at his clinic some 80 percent of patients report they suffer less pain, stiffness and weakness within several months of receiving their first stem-cell injections. As far as Health Canada is concerned, the greater number of stem-cell therapies represent the use of a 'drug' requiring official authorization following a clinical trial, or should alternately undergo the process of a new drug submission.

In the United States, the U.S. Food and Drug Administration is pursuing the hundreds of clinics in operation there offering stem-cell treatments. Health Canada "will take action based on the risk posed to the general public" states Eric Morrissette, department spokesman. He points out that one treatment has been approved, where bone marrow transplants to treat cancer instead attack the patient's body, and so the stem-cell treatment is designed to combat "graft-versus-host disease".

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